Tooth LossNCT04605016
Clinical Performance of Dentals Implants With Hydrophilic or Hydrophobic Surfaces
A study testing Hydrophilic surface implants and Hydrophobic surface implants in people with Tooth Loss, run by Universidade Federal de Goias at 1 site in Brazil.
Trial summary
The aim of the study is to compare longitudinally the clinical performance of dental implants with different surfaces placed in single tooth gaps at the posterior maxilla and mandible of adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tooth Loss
- What is being tested?
- Hydrophilic surface implants and Hydrophobic surface implants
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Apr 2021to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Present single or multiple intercalated untreated tooth gaps in the posterior region of the mandible or maxilla;
- Agree to participate in the study by signing the informed consent form.
Who cannot join
- Unavailability for participation or signs that they could not comply with the schedule of follow-up visits;
- Presence of general and/or local contraindications that could prevent the surgical procedure for implant placement;
- Presence of conditions that may interfere with the prognosis, such as current treatment with bisphosphonates or report of use for less than 2 years, presence of rheumatic diseases, among others;
- Absence of the minimum bone quantity of 8 mm in length and 3.75 mm in diameter for installation of an implant in the tooth gap;
- Absence of a mesio-distal space of at least 4.6 mm in the single tooth gap required to place the surgical guide;
- Do not present a mouth opening of at least 12mm required for the proper of the guided surgical kit together with the surgical guide;
- Do not present a band of keratinized tissue favorable for maintaining peri-implant health.
- Present motor difficulties that compromise adequate oral hygiene.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Faculty of Dentistry of the Federal University of Goias
Goiânia, Goiás
About this study
Official title: Clinical Performance of Dental Implants With Hydrophilic or Hydrophobic Surfaces in Single Posterior Edentulous Spaces: a Randomized Clinical Trial
The aim of the study is to compare longitudinally the clinical performance of dental implants with different surfaces placed in single tooth gaps at the posterior maxilla and mandible of adults. It is a randomized clinical trial, in which participants will be randomly allocated to two groups: test group (implants with hydrophilic surface) and control group (implants with hydrophobic surface). The null hypothesis is that the implant stability quotient of hydrophilic and hydrophobic dental implants show a similar progression after placement in posterior tooth gaps.
- Conditions
- Tooth Loss
- Being tested
- Hydrophilic surface implants, Hydrophobic surface implants
- Keywords
- single tooth gap, missing tooth
- Medical subject headings
- Tooth Loss, Anodontia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrophilic surface implantsDevice
Also called Neodent Helix Grand Morse® Acqua
A dental implant with hydrophilic surface will be placed and restored in single-tooh gaps of the posterior region of the mandible or maxilla.
Hydrophobic surface implantsDevice
Also called Neodent Helix Grand Morse® Neoporos
A dental implant with hydrophobic surface will be placed and restored in single-tooh gaps of the posterior region of the mandible or maxilla.
| Study group | Role | What they receive |
|---|---|---|
| Hydrophilic surface implants | Experimental | Not described Receives: Device: Hydrophilic surface implants |
| Hydrophobic surface implants | Active comparator | Not described Receives: Device: Hydrophobic surface implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of implant stability
Implant stability was set as the primary outcome. The implant stability quotient (ISQ) will be measured using a portable device called Osstell ISQ (Osstell Mentor, Integration Diagnostics, Göteborg, Sweden).
Measured: 10 time-points will be considered and divided in two phases: surgical and prosthetic. The last measure will occur 1 year after the placement of the definitive implant restoration.
Secondary outcomes (3)
Implant success
Each implant will be assessed according to the health scale of the International Congress of Oral Implantologists (ICOI-Pisa health scale). After clinical assessment, each implant will be classified as 'success', 'satisfactory survival', 'compromised survival' or 'failure'.
Measured: Assessed at the 12-month follow-up visit.
Periimplant bone level
Periapical radiographs will be obtained and the periimplant bone level will be measured and compared longitudinally.
Measured: Radiographs will be obtained at 4 time points: immediately after implant placement, at the session of the provisional prosthesis installation, and at the 6 and 12-month follow-up visits after the delivery of the definitive prosthesis.
Condition of the periimplant soft tissues
The following parameters will be assessed clinically: presence/absence of bleeding on probing, probing depth, and presence/absence suppuration.
Measured: 15-days, 6- and 12-month follow-up visits after delivery of the definitive prosthesis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start1 Apr 2021
- Primary completion11 Sep 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Goias
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cláudio Rodrigues Leles, Universidade Federal de Goias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04605016
- Sponsor's protocol ID
- PI04791-2020
- Status last verified
- May 2023
- First submitted
- 15 Oct 2020
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Dental Implants With Hydrophilic or Hydrophobic Surfaces in Single Posterior Edentulous Spaces: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04605016
- Acronym / sponsor ID
- PI04791-2020
- Conditions
- Tooth Loss
- Keywords
- single tooth gap, missing tooth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Universidade Federal de GoiasUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 11 Sep 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 27 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to compare longitudinally the clinical performance of dental implants with different surfaces placed in single tooth gaps at the posterior maxilla and mandible of adults. It is a randomized clinical trial, in which participants will be randomly allocated to two groups: test group (implants with hydrophilic surface) and control group (implants with hydrophobic surface). The null hypothesis is that the implant stability quotient of hydrophilic and hydrophobic dental implants show a similar progression after placement in posterior tooth gaps.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrophilic surface implants | Experimental | Device: Hydrophilic surface implants |
| Hydrophobic surface implants | Active comparator | Device: Hydrophobic surface implants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Present single or multiple intercalated untreated tooth gaps in the posterior region of the mandible or maxilla;
- Agree to participate in the study by signing the informed consent form.
Key exclusion criteria (8 listed)
- Unavailability for participation or signs that they could not comply with the schedule of follow-up visits;
- Presence of general and/or local contraindications that could prevent the surgical procedure for implant placement;
- Presence of conditions that may interfere with the prognosis, such as current treatment with bisphosphonates or report of use for less than 2 years, presence of rheumatic diseases, among others;
- Absence of the minimum bone quantity of 8 mm in length and 3.75 mm in diameter for installation of an implant in the tooth gap;
- Absence of a mesio-distal space of at least 4.6 mm in the single tooth gap required to place the surgical guide;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrophilic surface implantsAlso: Neodent Helix Grand Morse® AcquaA dental implant with hydrophilic surface will be placed and restored in single-tooh gaps of the posterior region of the mandible or maxilla. | Device | Hydrophilic surface implants |
| Hydrophobic surface implantsAlso: Neodent Helix Grand Morse® NeoporosA dental implant with hydrophobic surface will be placed and restored in single-tooh gaps of the posterior region of the mandible or maxilla. | Device | Hydrophobic surface implants |
Primary outcome
Change of implant stability
Time frame: 10 time-points will be considered and divided in two phases: surgical and prosthetic. The last measure will occur 1 year after the placement of the definitive implant restoration.
Implant stability was set as the primary outcome. The implant stability quotient (ISQ) will be measured using a portable device called Osstell ISQ (Osstell Mentor, Integration Diagnostics, Göteborg, Sweden).
3 secondary outcomes
Implant success
Time frame: Assessed at the 12-month follow-up visit.
Periimplant bone level
Time frame: Radiographs will be obtained at 4 time points: immediately after implant placement, at the session of the provisional prosthesis installation, and at the 6 and 12-month follow-up visits after the delivery of the definitive prosthesis.
Condition of the periimplant soft tissues
Time frame: 15-days, 6- and 12-month follow-up visits after delivery of the definitive prosthesis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrophilic surface implants and Hydrophobic surface implants in people with Tooth Loss, run by Universidade Federal de Goias at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of implant stability (time frame: 10 time-points will be considered and divided in two phases: surgical and prosthetic. The last measure will occur 1 year after the placement of the definitive implant restoration.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.